Natural orifice surgery system

ABSTRACT

Embodiments of a surgical access port system that comprises a retractor that is adapted for being coupled to a cap and that is particularly useful in natural orifice surgery are described. The retractor comprises an outer ring, wherein the outer ring is configured to be disposed proximate the natural orifice of the patient and substantially surround the orifice; a tubular body; and various stabilizing mechanisms surrounding the tubular body, sized and configured to stabilize and retain the retractor within the orifice. The stabilizing embodiments described herein are useful in all natural orifices and are of particular use in the vaginal surgery.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/826,336 filed Aug. 14, 2015 entitled “Natural orifice surgerysystem,” which claims the benefit of U.S. Provisional Patent ApplicationSer. No. 62/038,082, filed Aug. 15, 2014 entitled “Natural orificesurgery system,” the entire disclosures of which are incorporated byreference.

BACKGROUND Technical Field

This application is generally directed to surgical devices, and moreparticularly, to an access device adapted for use with a cap, that isuseful in natural orifice single-port surgical procedures and which isparticularly useful in vaginal surgical procedures.

Description of the Related Art

Access devices are commonly used in surgery to facilitate theintroduction of various surgical instruments into natural biologicalvessels, conduits, orifices, cavities, and other interior regions of thebody. These access devices include, for example, devices that facilitatethe introduction of a needle into a vessel, and trocars that facilitatethe introduction of laparoscopic instruments into the abdomen of thebody.

Some of these access devices are introduced into regions that include afluid or gas under pressure. In the case of a needle access device, thepressure may be from a liquid, such as blood. In the case of a trocar,the pressure may be from a gas, such as an insufflation gas. In eithercase, it is desirable to provide for the introduction of the surgicalinstrument into the cavity without permitting the escape of thepressurized fluid or gas.

In the case of trocars, a cannula at the distal end of the trocar istypically connected to a seal housing at the proximal end of the trocar.Together the cannula and housing form a working channel through whichvarious instruments can be inserted to access the cavity. Sealmechanisms are commonly disposed in the housing and include a septumvalve that seals the working channel when an instrument is in place, anda zero closure valve that seals the working channel when the instrumentis removed.

Current surgical access ports allow for single instrument access througheach port, or allow for multiple instrument access through a rigidcannula. Some devices, such as transanal endoscopic microsurgery (TEMS)units require that the device be attached to the surgical table tosupport the weight of the device, as well as to locate the position ofthe device respective to the patient. These devices do not provideflexibility to the surgeon in selecting instrument size, and theyrestrict instrument movement with their rigid cannulas. Additionally,surgeons are performing laparoscopic surgical procedures through asingle or a limited number of access ports. The procedures may beperformed through a single two (2) centimeter incision at the umbilicus,or in certain cases, trans-vaginally or trans-anally. What is needed isa system that meets the needs of these new procedures, facilitating moreflexible movement of laparoscopic instruments through a single orlimited number of ports while preventing the escape of pressured fluidsor gasses and permitting large specimen removal. What is particularlyneeded is an access system that can be deployed into a natural bodycavity, such as the vagina, providing a sealed system for insufflationand a platform for the introduction of multiple surgical instruments ofvarying sizes, while maintaining sufficient stability for anchoring thesystem within the cavity without damaging the body cavity wall.

SUMMARY OF THE INVENTION

The invention is directed to a surgical access port system adapted forperforming surgical procedures at a natural orifice comprising, an outerring, wherein the outer ring is configured to be disposed proximate thenatural orifice of the patient; a tubular body having a longitudinalaxis, a proximal end and a distal end; a funnel segment extendingbetween and coupling the outer ring and the proximal end of the tubularbody, wherein the funnel segment provides a diametric reduction betweenthe outer ring and the tubular body; and a flange disposed around thetubular body, the flange comprising a circular ridge circumscribing achannel, wherein the flange is adapted to secure the retractor withinthe body orifice. The flange may be disposed around the distal or theproximal end of the tubular body.

Optionally, the surgical access port system further comprises aremovable gel cap, wherein the gel cap comprises a gel pad and a capring coupled with the gel pad, wherein the cap ring is engagable withthe outer ring.

In another embodiment, the surgical access port system comprises anouter ring, wherein the outer ring is configured to be disposedproximate the natural orifice of the patient; a tubular body having alongitudinal axis, a proximal end and a distal end; a funnel segmentextending between and coupling the outer ring and the proximal end ofthe tubular body, wherein the funnel segment provides a diametricreduction between the outer ring and the tubular body; and afrustoconical bolster disposed around the tubular body, the bolstercomprising a first diameter at a distal end and a second diameter at aproximal end, the second diameter being larger than the first diameter,wherein the bolster is adapted to externally occlude the naturalorifice.

In some embodiments, the bolster comprises at least one of a thermosetpolymer and a thermoplastic elastomer. In some embodiments, the bolsteris fixed around the proximal end of the tubular body. Optionally, theaccess system further comprises a flange disposed around the tubularbody, distal to the bolster and/or an inflatable balloon disposed aroundthe tubular body, distal to the bolster. In some embodiments, thebolster is slidably engaged with the tubular body.

In another embodiment, the surgical access port system comprises anouter ring, wherein the outer ring is configured to be disposedproximate the natural orifice of the patient; a tubular body having alongitudinal axis, a proximal end and a distal end; a funnel segmentextending between and coupling the outer ring and the proximal end ofthe tubular body, wherein the funnel segment provides a diametricreduction between the outer ring and the tubular body; a mechanicalballoon disposed around the tubular body, the mechanical ballooncomprising a series of arms disposed along the longitudinal axis of thetubular body, each arm having a proximal end attached to a first ringand a distal end attached to a second ring, wherein the second ring isfixed to the tubular body; and a third ring disposed around the tubularbody proximal to the first ring, the third ring adapted to move alongthe tubular body to engage the first ring and push the first ring towardthe distal end of the tubular body, thereby placing a load on the armsand causing them to flare out from the tubular body. The mechanicalballoon may also be used in combination with a compression flange or abolster cone.

Optionally, the arms comprise a semi-rigid material. In someembodiments, each of the arms further comprises an articulating jointalong the length of the arm.

In another embodiment, the surgical access port system comprises anouter ring, wherein the outer ring is configured to be disposedproximate the natural orifice of the patient; a tubular body having alongitudinal axis, a proximal end and a distal end; a funnel segmentextending between and coupling the outer ring and the proximal end ofthe tubular body, wherein the funnel segment provides a diametricreduction between the outer ring and the tubular body; and an inflatablesaddle-shaped balloon disposed around the tubular body, thesaddle-shaped balloon comprising a first peak and a second peak, thesecond peak displaced from the first peak along the longitudinal axis ofthe tubular body. In some embodiments, the saddle-shaped balloon isadapted to compress the tissue of the natural orifice between the firstpeak and the second upon inflation to thereby occlude the naturalorifice.

In another embodiment, the surgical access port system comprises anouter ring, wherein the outer ring is configured to be disposedproximate the natural orifice of the patient; a tubular body having anexterior surface, a longitudinal axis, a proximal end and a distal end;a funnel segment extending between and coupling the outer ring and theproximal end of the tubular body, wherein the funnel segment provides adiametric reduction between the outer ring and the tubular body; aretaining sleeve, the retaining sleeve comprising a longitudinal axis, aproximal end, a distal end, and a lumen, wherein the tubular body isdisposed within the lumen and adapted to move along the longitudinalaxis of the retaining sleeve; and at least two arms, each arm connectedto the distal end of the retaining sleeve with an articulating hinge,wherein the arms are movable from a closed position to an open positionas the distal end of the tubular body engages the arms.

Optionally, each arm further comprises an angled lead near thearticulating hinge, the lead positioned to engage the distal end of thetubular body as the tubular body is moved through the retaining sleeve.In some embodiments, the access port further comprises an externalthread wrapped around the exterior of the tubular body and an internalthread wrapped around an interior surface of the lumen of the retainingsleeve, wherein the external thread is adapted to engage the internalthread. In other embodiments, the access port further comprises aplurality of teeth disposed along the exterior surface of the tubularbody and a plurality of pawls disposed along an interior surface of thelumen of the retaining sleeve, wherein the teeth are adapted to engagethe pawls to facilitate unidirectional movement of the tubular bodythrough the lumen of the retaining sleeve.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a patient in surgery illustrating an embodimentof the access device positioned on the abdomen and in use.

FIG. 2 is a cross-sectional side view illustrating an embodiment of theaccess device, with the wound retractor retracting the vagina of apatient, and the gel cap sealing the opening of the wound retractor.

FIG. 3 is a front view illustrating an embodiment of the access devicedeployed and in use at the mouth of the patient.

FIG. 4 is a top view illustrated a patient in the prone position with anembodiment of the access device deployed and in use at the anus of thepatient.

FIG. 5A is a picture of the components of an access device system usefulfor natural orifice surgery; FIG. 5B is a perspective view of theretractor of FIG. 5A.

FIG. 6A is a perspective view of an embodiment of a natural orificeretractor having an occlusion flange. FIG. 6B is a side cut away of thenatural orifice retractor of FIG. 6A.

FIG. 6C is a side view of an embodiment of a natural orifice retractorhaving a compression flange. FIG. 6D is a side cut away of the naturalorifice retractor of FIG. 6C.

FIG. 6E is a perspective view of an embodiment of a natural orificeretractor having a bolster cone.

FIG. 6F is a side view of an embodiment of a natural orifice retractorhaving a mechanical balloon, shown in an uncompressed state. FIG. 6G isa side view of the natural orifice retractor of FIG. 6F, shown in acompressed, or expanded, state.

FIG. 6H is a perspective view of an embodiment of a natural orificeretractor having a balloon.

FIG. 6I is a perspective view of an embodiment of a natural orificeretractor having a saddle balloon.

FIG. 6J is a perspective view of an alternative embodiment of aretractor having an inflatable member.

FIG. 6K is a cutaway side view showing the check valve and channeldisposed in the tubular body of the retractor.

FIG. 6L is a perspective view of an embodiment of a natural orificeretractor having a balloon and a bolster.

FIG. 6M is a perspective view of an embodiment of a natural orificeretractor adapted to provide retraction and access without insufflation,shown in an open configuration. FIG. 6N is a cross-sectional view of theembodiment of a natural orifice retractor of FIG. 6M. FIG. 6O is aclose-up side view of the screw threads disposed around the retainingsleeve and the tubular body of the retractor. FIG. 6P is across-sectional view of the embodiment of FIG. 6M, shown in a closedconfiguration.

FIG. 6Q is a close-up side view of the ratcheting mechanism forattaching the retaining sleeve to the tubular body of the retractor.

FIG. 7A is a perspective view of an obturator adapted to facilitateintroduction of a natural orifice retractor into a body orifice such asa vagina. FIG. 7B is a side view of the obturator of FIG. 7A.

FIG. 7C is a perspective view of an obturator having a straight shaftpiece, adapted to facilitate introduction of a natural orifice retractorinto a body orifice such as a vagina. FIG. 7D is a perspective view of aretractor disposed on the obturator of FIG. 7C.

FIG. 7E is a perspective view of an obturator, modified with an indentto provide clearance for the inflation port shown in FIGS. 6I and 6J andadapted to facilitate introduction of a natural orifice retractor into abody orifice such as a vagina.

FIG. 8A is a side view of the natural orifice access device of FIG. 5A.FIG. 8B is a top view of the natural orifice access device illustratedin FIG. 5A. FIG. 8C is a perspective view of the natural orifice accessdevice illustrated in FIG. 5A.

FIG. 9A is a perspective view of an embodiment of a natural orificeaccess device including a cap having a plurality of ports extendingthere through.

FIG. 9B is an exploded view of an embodiment of a port and optionalobturator, which is a component of some embodiments of the access devicesystem.

FIG. 10A is a top perspective view of an embodiment of a gel cap. FIG.10B is a bottom view of an embodiment of a cap ring.

FIG. 11A is a top view of an embodiment of a gel cap comprising aplurality of access ports embedded in the gel pad. FIG. 11B is a topperspective view of the gel cap illustrated in FIG. 11A. FIG. 11C is abottom perspective view of the gel cap illustrated in FIG. 11A.

FIG. 11D is a top perspective view of the gel cap illustrated in FIG.11A with instruments inserted through two of the access ports. FIG. 11Eis a bottom perspective view of the gel cap and instruments illustratedin FIG. 11D. FIG. 11F is a side view of the gel cap and instrumentsillustrated in FIG. 11D.

FIG. 11G is a top perspective view of an embodiment of gel capcomprising a fixed camera or laparoscope port.

FIG. 12 is a cutaway perspective view of an embodiment of an accessdevice system comprising a gel cap that snap fits to a retractor.

FIG. 13 is an exploded view of an embodiment of a trocar.

FIGS. 14A and 14B are side views of an embodiment of a trocar comprisinga fixation cannula in an insertion configuration and a fixationconfiguration, respectively.

FIG. 15 is a side view of another embodiment of a trocar comprising afixation cannula.

FIG. 16A is a side view of another embodiment of a trocar comprising afixation cannula. FIG. 16B is a perspective view of an embodiment of abolster suitable for use with the trocar illustrated in FIG. 16A.

FIG. 17A is a side view of another embodiment of a trocar comprising afixation cannula. FIG. 17B is a perspective view of an embodiment of abolster suitable for use with the trocar illustrated in FIG. 17A.

Similar components have similar reference numbers throughout.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

Embodiments of a surgical instrument access device system are useful,for example, for single incision, single port, and/or limited portlaparoscopic surgical procedures, for example, abdominal (FIG. 1),transvaginal (FIG. 2), transoral (FIG. 3), and transanal (FIG. 4)procedures. Various surgical instrument access devices are described inU.S. Patent Application Publication No. 2009/0187079, entitled “SURGICALINSTRUMENT ACCESS DEVICE,” filed Jan. 22, 2009, and U.S. Pat. No.7,727,146, entitled “WOUND RETRACTOR WITH GEL CAP,” both of which areincorporated by reference in their entireties herein.

FIG. 5A shows an embodiment of an access device system comprising aretractor 6100, an introducer 6400 shown inserted into the retractor asif for placement in a body orifice, a cap 6200, one or more ports 6310,and an obturator 6600, which is useful in single port and/or limitedport procedures. The retractor 6100 is placed and/or positioned into,across, and/or through a surgical incision and/or body orifice toenlarge, reshape, and/or isolate the incision or body orifice. The cap6200 provides an artificial body wall through which instruments accessthe interior of a patient's body, for example, a body cavity, throughports 6310. The retractor 6100 may be introduced into an orifice usingthe introducer 6400; ports 6310 may be placed through the gel cap usingobturator 6600. The components of the access device comprise anysuitable biologically compatible materials.

With the gel cap 6200 attached to the retractor 6100, the access devicesystem allows the user to insufflate the orifice, such as the vaginalcanal. The distention of the canal caused by the insufflation providesgreater visualization of the anatomy (when compared, for example, totraditional vaginal hysterectomy) and removes the need for the use ofrigid mechanical retractors which may cause damage to soft tissues. Thegel cap may be detached at any point during the surgical procedure toallow for specimen removal.

The retractor 6100 is made of a semi-pliable thermoplastic elastomer orthermoset polymer. For use in vaginal procedures, a length ofapproximately 4 cm to 7 cm and a diameter of approximately 3 cm to 5 cmwill suit a range of anatomies. The retractor retracts and occludes thevagina. Suture ties 6160 at proximal end 6152 and/or a flange 6110 alongthe tubular body may help prevent the retractor from dislodging onceplaced. The gel cap 6200 may be attached with the aid of a lever 6135which locks under the proximal ring 6120 of the retractor 6100. Thiscreates a pressure resistant seal and insufflation is possible throughinsufflation ports 6145 on the gel cap. Smoke evacuation is possiblethrough the port not being used for insufflation. Instrument ports 6310may be placed in the gel cap 6200 to allow for the use of variouslaparoscopic instruments. The gel cap may then be detached and specimensmay be removed through the retractor 6100.

Turning to FIG. 5B, the outer ring 6120 is proximal a funnel section6140. In the illustrated embodiment, the outer ring 6120 has asubstantially circular footprint. As further discussed herein, the outerring 6120 can be sized and configured to sealingly couple to a cap orother access device thereon. In some embodiments, one or more suturepoints 6160 can be disposed on the retractor 6100 adjacent the outerring 6120. Two suture points 6160 are generally diametrically opposedrelative to the generally circular profile of the outer ring 6120. Inother embodiments, the retractor can include more or fewer than twosuture points disposed of various locations relative to the outer ring6120.

With continued reference to FIG. 5B, the tubular body 6130 has agenerally circular profile defining a generally cylindrical passage6150. The generally cylindrical passage is desirably large enough toaccommodate more than one laparoscopic instrument there through suchthat a single natural orifice access device can be used to provideaccess for multiple surgical instruments in a body cavity. Moreover,generally cylindrical passage is desirably large enough such thatmultiple surgical instruments positioned there through can be translatedor pivoted relative to one another, allowing a surgeon to manipulate theinstruments as desired during a surgical procedure. The generallycylindrical passage extends between a proximal end 6152 of the retractor6100 adjacent the outer ring 6120 to a distal end 6154 of the retractor6100 adjacent the flange 6110. In FIGS. 5A and 5B, the tubular body 6130has a circular cross-section. In other embodiments, the tubular body6130 has another shape, for example, an oval cross section, an octagonalcross-section, or other shapes as may be appropriate for the naturalorifice of interest. Some embodiments of the tubular body 6130 compriseone or more coatings that provide additional functionality, for example,an anti-microbial coating.

In the illustrated embodiment, the funnel segment 6140 provides adiametric reduction between the relatively large diameter of the outerring 6120, which is sized and configured to be removably coupled to anaccess device such as a cap, and the relatively smaller diameter of thepassage 6150, which is sized to fit within a natural orifice withminimal distention of the orifice. The funnel segment 6140 has an innersurface which can provide a bearing surface for an obturator orintroducer used to advance to the retractor 6100 into a body cavity. Insome embodiments, the funnel segment can have a substantially lineartaper between the relatively large diameter and the relatively smallerdiameter such that the inner surface is a frustoconical segment. Inother embodiments, the funnel segment 5 can have a curved profilebetween the relatively large diameter and the relatively smallerdiameter. In some embodiments, there is no funnel section at all, aswhere the tubular body connects directly to the outer ring.

It can be desirable that the outer ring 6120 is relatively stiffcompared with the relatively flexible tubular body 6130 of the retractor6100 so that the outer ring 6120 can sealingly engage an access devicesuch as a cap. With reference to FIG. 5B, a perspective view of theretractor is illustrated with a partial cutaway of the outer ring 6120.In the illustrated embodiment, the outer ring 6120 includes an annulargroove 6122 formed therein in which a reinforcing member 6124 isdisposed. In some embodiments, the reinforcing member 6124 can comprisea metallic member such as a wire formed into a ring shape. For example,in some embodiments the reinforcing member 6124 can comprise a stainlesssteel ring positioned within the groove 6122 during manufacture of theretractor 6100. In other embodiments, the reinforcing number 6124 cancomprise an injectable nonmetallic member. For example, in someembodiments, a glass filled polymer or polycarbonate material can beinjected into the groove 6122 during manufacture of the retractor 6100.

While the illustrated embodiments of retractor 6100 include areinforcing member to enhance the rigidity of the outer ring 6120, inother embodiments, the retractor 6100 can be formed in a multiple-shotmolding process. For example, in some embodiments, an inner segment ofthe retractor defined by the tubular body 6130 and the flange 6110 isformed in one molding operation from a flexible material, and an outersegment of the retractor 6100 defined by the funnel segment 6140 and theouter ring 6120 is formed in another molding operation from a relativelyrigid material such as a polycarbonate material or other suitablematerial.

With continued reference to FIG. 5B, the illustrated embodiment includesa continuous generally annular groove. In other embodiments, a pluralityof noncontiguous recesses can each receive one of a plurality ofreinforcing members. Moreover, in some embodiments, the outer ring caninclude two or more concentric generally annular grooves, which eachreceive a corresponding reinforcing member.

Various types of flanges may be used to help secure the retractor in thebody orifice. One embodiment of the natural orifice access deviceretractor 6100 illustrated in FIG. 6A can be adapted for use in atransvaginal surgical procedure. The retractor 6100 comprises anocclusion flange 6111, an outer or proximal ring 6120, and a tubularbody 6130 and a funnel segment 6140 extending between and coupling theocclusion flange 6111 and the outer ring 6120. The occlusion flange 6111is semi-rigid, with a diameter from approximately 2 inches to 4 inches.When inserted into the orifice, for example, the vagina, the flange isunder compression from the walls of the vaginal canal, creating a sealto aid in the maintenance of insufflation. In some embodiments, theocclusion flange is “cup-shaped” with a circular ridge 6109circumscribing a channel 6107, which provides sufficient flexibility toallow the flange 6111 to flex to accommodate different anatomies whilestill maintaining a seal.

With reference to FIG. 6C, a side view of a retractor 6100 for use inthe natural orifice access device system having a different flangeembodiment is shown. In this embodiment, the retractor 6100 is shownwith a compression flange 6112. The compression flange 6112 isapproximately 2 inches to 4 inches in diameter and is disposed aroundthe retractor distal to the outer or proximal ring 6120. The distancebetween the compression flange and the outer ring is designed to be lessthan the thickness of the tissues comprising the natural orificeopening. In the case of the vaginal opening, the distance isapproximately 0.1 inches to 0.5 inches. This creates a compressive forceon the tissue between the flange and outer ring of the retractor. Thisforce and the “cup-shaped” geometry of the flange (see FIG. 6D) occludethe vagina and serve to prevent dislodging. Suture ties 6160 may be usedto mitigate dislodging.

With reference to FIG. 6E, a perspective view of a retractor 6100 foruse in the natural orifice access device system having still anotherflange embodiment is shown. In this embodiment, the retractor 6100 isshown with a bolster cone 6113. The soft thermoset polymer orthermoplastic elastomer bolster cone (tapered with maximum diameterapproximately 2 inches to approximately 4 inches for use in the vagina)may be added to the retractor. In use, the retractor is advanced intothe body orifice, such as a vagina, while the bolster cone serves as astop to externally occlude the vagina. The bolster cone may be fixed ormobile along the tubular body 6130 of the retractor 6100. The sutureties 6160 prevent the retractor from dislodging and maintain compressionof the bolster cone against the orifice opening. The design mayoptionally include a flange similar to others described herein.

With reference to FIGS. 6F and 6G, a side view of a retractor for use inthe natural orifice access device system having a different flangeembodiment is shown. In this embodiment, the retractor is shown with amechanical expanding feature (a “mechanical balloon”) 6114. Themechanical balloon comprises a series of arms 6105 that runcircumferentially around the channel 6130, the arms attached at to afirst ring 6103 and a second ring 6101. The first ring is movable alongthe length of the channel, while the second ring is fixed at or near thedistal end of the channel. A sliding third ring 6102, disposed aroundthe tubular channel proximal to the first ring, may be advanced towardthe distal end of the channel, putting the arms under a load that causesthem to flare outwards to assume a balloon-like shape, shown in FIG. 6G.The arms exert a force on the anatomy of the natural orifice, causingthe retractor to be anchored in place without damaging the surroundingtissue.

In some embodiments, the sliding third ring is threaded along itsinterior surface and is adapted to engage with threads disposed aroundthe channel. See FIG. 6G. In other embodiments, a ratcheting mechanismmay be used to move the sliding third ring along the channel.

The sliding ring may comprise any rigid or semi-rigid material, plasticor metal, while the arms may comprise a semi-rigid metal or plasticsufficiently flexible to flare outwards under a load. Alternatively, thearms may comprise a rigid material with an articulating joint locatedapproximately mid-length of each arm, facilitating a similar flaring.

The mechanical balloon has a diameter of approximately 2 inches toapproximately 4 inches and is disposed around the tubular body at thedistal end of the retractor. The mechanical balloon may be coated in anon-porous, flexible material to permit occlusion and prevent dislodgingwhen expanded or non-coated to serve solely for fixation. The amount ofexpansion may be variable to accommodate different anatomies. Thefeature is initially unexpanded to ease insertion and is then expandedas needed.

In some embodiments, the mechanical balloon may be used in combinationwith a compression flange as shown in FIG. 6C. In this embodiment, thecompression flange is disposed around the tubular body proximal to themechanical balloon and helps seal the retractor within the naturalorifice. In an alternative embodiment, the mechanical balloon may beused in combination with a bolster cone, as shown in FIG. 6E. Thebolster cone will act to seal the retractor within the orifice while themechanical balloon helps anchor it.

In other embodiments, shown in FIGS. 6H-J, the flange can comprise aninflatable member 6132 such as an annular balloon coupled to a gas orfluid source that can be selectively inflated and deflated between adeflated, relatively small diameter state for insertion and removal, andan inflated, relatively high diameter state for retention in a bodycavity. An inflation port 6134, for example a check valve, affixed tothe funnel portion 6140 of the retractor, is connected to the inflatablemember 6132 through a channel 6136 within the wall of the tubular body6130. Fluid or gas introduced through the inflation port flows throughthe channel into the inflatable member to thereby inflate the member.

The channel 6136 runs through the tubular body, generally parallel tothe longitudinal axis of the tubular body, with a proximal openinginteracting with the inflation port 6134 and a distal opening 6139 intoouter surface of the tubular body at the inflatable member. In oneaspect, the inflation port 6134 may include a normally closed checkvalve having a spring-loaded plunger. In a further aspect, the checkvalve may include a Luer lock. It is contemplated that other inflationports that are well known in the art may be used.

In this embodiment, the tubular body 6130 is preferably comprised of arelatively rigid material, such as a polycarbonate. The tubular body hasan inflatable member at the distal end that may be created by heatshrinking polyolefin tubing around the outside of the tubular body. Thedistal end of the body/tubing assembly is then heated for approximately30 to 40 seconds, and then placed inside a mold and injected with air togive the inflatable member an annular balloon shape as seen in FIG. 6H,or any other desired shape, depending on the configuration of the mold.The inflatable member 6132 should have sufficient impermeabilityproperties to substantially prevent inflation gas or fluid frompermeating through a wall of the inflatable member.

In one embodiment, the inflatable member 6132 may include asubstantially toroid shape upon inflation (see FIG. 6H). In anotherembodiment, the inflatable member may include a disc shape uponinflation. In another embodiment, the inflatable member 6132 may be afluted balloon. In still another embodiment, the inflatable member is asaddle shaped balloon 6116, as shown in FIG. 6I. For use in vaginalsurgery, the saddle shaped balloon in this embodiment is tapered withmaximum diameter from approximately 2 inches to approximately 4 inches.The balloon is initially deflated for ease of entry into the vagina andthen may be inflated by through an inflation port 6134 on the proximalend of the retractor. The vaginal opening seats in the low point of thesaddle and is compressed between the peaks of the saddle as the balloonis inflated. This occludes the vagina, both internally and externally,and prevents dislodging. The balloon also distributes forces appliedduring the procedure over a greater area, reducing possible damage totissue. Suture ties may also be used to mitigate dislodging. The balloonis then deflated upon completion of the procedure to ease removal. Othershapes suitable for particular natural orifices will be appreciated byone skilled in the art.

In use, the inflatable member may be inflated after the retractor isdisposed within the natural orifice by inserting a syringe into thevalve 6134 located at the proximal end 6138 of the channel within thetubular body (see FIG. 6K). As shown in FIGS. 6J and 6K, the port leadsinto the channel 6136, which allows the fluid or gas from the syringe totravel to the inflatable member 6132. Alternatively, a bulb pump orother source of gas or fluid may be used to inflate the inflatablemember.

In still another embodiment, the bolster cone described herein may becombined with an inflatable member, as shown in FIG. 6L. In thisembodiment, the retractor has a balloon 6132 at the distal end and abolster cone 6113 mid-channel. For use in vaginal procedures, theballoon has a diameter from about 2 inches to about 4 inches while thebolster cone is tapered with a maximum diameter of about 2 inches toabout 4 inches. The balloon 6132 is initially deflated for ease of entryinto the vagina and then may be inflated through a port 6134 on theproximal end of the retractor. The amount of inflation may be variableto accommodate different anatomies. The balloon occludes the vagina wheninflated and prevents the retractor from dislodging while causingcompression of the bolster cone against the vaginal opening to furtherocclude. The bolster cone distributes forces applied during theprocedure over a greater area, reducing possible damage to tissue.Suture ties may also be used to mitigate dislodging. The balloon is thendeflated upon completion of the procedure to ease removal.

Another embodiment of the natural orifice access system, configured toprovide retraction and access without using insufflation gases, is shownin FIGS. 6M-6P. In some natural orifices, for example, the vagina,pressure from a standard insufflator can be insufficient to maintain avisible, stable surgical working space due to leaks and billowingcreated by surges from the insufflator. In this embodiment, theretractor 6100 has a proximal ring 6120 and a tubular body 6130, withthe tubular body adapted to engage a retaining sleeve 6143. Theretaining sleeve includes a lip 6144 at the proximal end and at leasttwo retracting arms 6146 at the distal end. The retracting arms areconnected to the retaining sleeve with an articulating hinge 6147 thatallows the arms to move between a closed position (FIG. 6P), in whichthe distal ends of the arms in proximity, and an open position (FIGS.6M, 6N), in which the distal ends of the arms are moved away from eachother. Optionally, the retracting arms may include an angled lead 6148near the hinge 6147.

In the embodiment of FIGS. 6M-6P, the tubular body includes an externalthread 6149 wrapped around the exterior of the tubular body, adapted toengage an internal thread 6151 disposed around the surface of theinterior lumen of the retaining sleeve 6143. See FIG. 6O.

In an alternative embodiment, a ratcheting mechanism comprising teeth6153 and a series of pawls 6155 may be used instead of internal andexternal threads (see FIG. 6Q). The ratchet mechanism allows theretractor to advance through the lumen of the retaining sleeve withrelative ease while resisting backwards movement until the sides of thetubular body of the retractor are manually depressed to release theratchet mechanism.

In use, the tubular body 6130 of the retractor 6100 is advanced forwardthrough the lumen of the retaining sleeve 6143 until contact is madewith the retracting arms 6146. The angled lead 6148 on the retractingarm allows for the opening to occur at an incremental rate toaccommodate a variety of anatomies. The lip 6144 on the retaining sleeveensures that the proximal end of the lumen will not enter the orificeand provides a holding point during the advancement of the retractor. Asseen in FIGS. 6M and 6N, the fully advanced channel presses on theretracting arms, causing them to flare out and hold open the vaginalcanal. With the tissue of the vaginal canal retracted, direct access isavailable to the cervix and surrounding tissue. In FIG. 6P, theretractor is drawn back; the retracting arms are disengaged and are ableto fold together. This state facilitates insertion and removal from theorifice.

In some embodiments, a natural orifice access system can include aretractor 6100 and an optional obturator 6400 (FIG. 7A-7B). Theobturator can have a proximal bearing surface 6410 sized and configuredto bear against the inner surface 6142 of the funnel segment 6140 and adistal dilation surface 6420 sized and configured to expand a naturalorifice for passage of the retractor 6100. Thus, during insertion of theretractor 6100 into a natural orifice, the dilation surface 6420 expandsa pathway to a surgical site in a body cavity while the obturator bearson the inner surface 6142 of the funnel segment 6140 to advance theretractor 6100 into position in the surgical site. Furthermore, in someembodiments, the obturator can have a handle 6430 at a proximal endthereof adapted to facilitate selective twisting or rotation of theobturator about a longitudinal axis thereof during insertion.

In an alternative embodiment, shown in FIG. 7C, the obturator 6405includes a straight shaft piece 6425 between the distal dilation surface6420 and the proximal bearing surface 6410 that facilitates dilation ofthe natural orifice prior to inserting the retractor. It can then becombined with the retractor 6100 to help ease insertion, as shown inFIG. 7D.

In embodiments having an inflatable member on the retractor, theoptional obturator 6400 may be modified with an indent 6139 to provideclearance for the inflation port, as shown in FIG. 7E.

With reference to FIG. 8A, a side view of a natural orifice accessdevice having a cap 6200 removably coupled to a retractor 6100 isillustrated. In the illustrated embodiment, the cap 6200 comprises asealable access surface 6210 such as a gel pad surface as described infurther detail herein. In certain embodiments, the cap 6200 can alsocomprise at least one gas or fluid port 6220, 6230. In the illustratedembodiment, the cap 6200 comprises two gas or fluid ports 6220, 6230,such that one port can be used for gas insufflation and the other portcan be used for ventilation for example when electrosurgery is performedthrough the access device. In certain embodiments, at least one of thegas or fluid ports 6220, 6230 comprises a valve such as a stopcock valveto selectively control the flow of fluid there through.

With reference to FIG. 8B, a top view of the natural orifice accessdevice is illustrated. The sealable access surface 6210 can be encircledby and restrained by an annular frame 6240 such as a split ring having aclamp 6250. The clamp 6250 can be movable between an open configurationin which the cap 6200 is selectively removable from the retractor 6100and a clamped configuration in which the cap 6200 can be secured to theretractor 6100. For example, the annular frame 6240 can be positionedperipherally around the outer ring 6120 with the clamp 6250 in the openconfiguration and the clamp moved to the clamped configuration tosealingly fix the cap 6200 to the retractor 6100. Accordingly, the cap6200 can be easily removed during a surgical procedure to facilitateremoval of excised tissue from a surgical site through the retractor6100.

With reference to FIG. 8C, a perspective view of the natural orificeaccess device is illustrated. In the illustrated embodiment, the clamp6250 can have a distal flange 6252 positioned to interface with theouter ring 6120 of the retractor when the clamp is in the clampedconfiguration. As illustrated, the clamp 6250 engages a distal surfaceof the outer ring 6120 of the retractor 6100. In some embodiments, theannular frame 6240 can further comprise at least one distal flange sizedand positioned to interface with a retractor. In the illustratedembodiment, the annular frame 6240 comprises a distal flange 6260positioned to engage a distal surface of the outer ring 6120 of theretractor. As illustrated, the flange 6260 is generally diametricallyopposed to the distal flange of the clamp 6250. In other embodiments,the annular frame 6240 can include more than one distal flangepositioned substantially equally spaced about the periphery of theannular frame 6240 or spaced irregularly about the periphery of theannular frame.

With reference to FIG. 9A, another embodiment of natural orifice accessdevice is illustrated with a cap 6300 removably coupled to a retractor6100. In the illustrated embodiment, the cap 6300 includes multipleports 6310 positioned through an access surface 6320 thereof.Advantageously, the multiple ports 6310 allow for easy placement andmanipulation of multiple laparoscopic instruments in a surgical sitethrough a single natural orifice.

In the illustrated embodiments of FIG. 9A, the ports 6310 have arelatively low profile, that is, protrude minimally above the accesssurface 6320 and/or below the distal surface of the cap 6300.Accordingly, the ports 6310 are shorter than a length of a typicaltrocar and comprise a seal assembly positioned above the access surface6320 and a cannula extending through the gel pad of the cap 6300. Thereduced length of the ports 6310 allows increased angular or pivotalmotion for instruments extending there through, and also permits the useof curved and/or angled instruments.

FIG. 9B is an exploded view of an embodiment of a port 6310 and optionalobturator 6600, which is a component of some embodiments of the accessdevice system. In the illustrated embodiment, the obturator 6600comprises a pointed, puncture tip 6610.

The port 6310 comprises a proximal end, a distal end, and a longitudinalaxis. The port 6310 comprises a cannula 6620 extending along thelongitudinal axis. A seal 6630 is disposed at the proximal end of thecannula 6620, contained within a housing 6640. A retainer 6650 isdisposed at the distal end or tip of the cannula 6620.

The cannula 6620 comprises a tubular body dimensioned to accommodate aninstrument or instruments received there through. In the illustratedembodiment, the cannula 6620 is a substantially cylindrical tube, andextends through the cap 6300 in use. In the illustrated embodiment, thecannula 6620 is comparatively short because the cannula need onlytraverse the cap 6300 (FIG. 9A), which has a known and consistentthickness, rather than a body wall. Accordingly, some embodiments of thecannula 6620 are not more than about 2-times longer, about 1.5-timeslonger, about 1.2-times longer, or about 1.1-times longer than thethickness of the gel pad. In some embodiments, the cannula 6620 is lessthan about 20 mm, about 10 mm, or about 5 mm longer than the thicknessof the gel pad. In some embodiments, the cannula 6620 is about as longas the gel pad is thick. In other embodiments, the cannula 6620 has adifferent length, for example, a length typical for a cannula used fortraversing a body wall. Shorter length cannula permit increased angulardegrees of freedom for instruments passing there through. Embodiments ofshorter cannula also accommodate curved instruments. The cannula 6620comprises any suitable biocompatible material. In some embodiments, thecannula 6620 comprises a flexible material.

The illustrated seal 6630 comprises an instrument or septum seal 6660and a zero seal 6670. Optionally, a shield 6680 may be disposed withinthe instrument seal 6660. The instrument seal 6660 seals instrumentspassing there through, thereby maintaining pressurization in a bodycavity such as pneumoperitoneum or pneumorectum. The zero seal 6670provides a seal when no instrument passes through the seal 6630. Theinstrument seal 6660 and zero seal 6670 are received in a housing 6640disposed at the proximal end of the cannula 6620 and secured therein bya seal cover 6690.

The retainer 6650 is disposed at or near the distal end of the cannula6620. In some embodiments, the retainer 6650 and cannula 6630 areintegrated, while in other embodiments, the retainer 6650 and cannula6630 are not integrated. In the illustrated embodiment, the proximal endof the retainer 6650 comprises a flange 6655 that is generally flat andperpendicular to the longitudinal axis, while the distal end is tapered,narrowing toward the distal end of the cannula 6620. The flange 6655reduces the likelihood of accidental or inadvertent removal of the port6310 from the cap. Some embodiments of the proximal face of the flange6655 comprise additional anchoring features, for example, at least oneof barbs, spikes, ridges, texturing, and the like, which are configuredto penetrate or bite into a distal face of the cap 6300. In someembodiments, a diameter of the flange 6655 is from about 1.2 to about2.5 times wider, or from about 1.5 to about 2.0 times wider than anouter diameter of the cannula 6630. Some embodiments of the port 6310are 5-mm trocars, in which the outer diameter of the cannula 6620 isfrom about 7 mm to about 8 mm.

The tapered end of the retainer 6650 facilitates insertion of the port6310 through the cap, either by itself, or when assembled with theobturator 6600 extending there through. For example, in someembodiments, the retainer 6650 is inserted through a preformed openingin the cap 6300.

In some embodiments in which the retainer 6650 and cannula 6620 are notintegrated, that is, are separate components, the retainer 6650 issecured to the cannula 6620 after the cannula 6620 is inserted throughthe cap. In some embodiments, the cannula 6620 and retainer 6650 aresecured mechanically, for example, using latches, screw threads, clips,lock rings, ratchets, and the like. In some embodiments, the cannula6620 and retainer 6650 are secured adhesively. In some embodiments, theposition of the retainer 6650 is adjustable, for example, to accommodatecaps of different thicknesses. In some embodiments, the cannula 6620and/or retainer 6650 is secured to the cap, for example, adhesively.

FIG. 10A illustrates in perspective an embodiment of a cap or cover10500, which is a surgical access device that seals the opening betweenthe body cavity and the area outside the body cavity while providingaccess into the body cavity from outside the body cavity. Moreparticularly, the illustrated cap 10500 releasably and sealingly couplesto the outer ring 6120 (FIG. 5), of the wound retractor. The cap 10500comprises a cap ring 10510 dimensioned and configured for coupling tothe outer ring 6120 of the wound retractor and a pad 10530 coupled tothe cap ring 10510. Embodiments of the cap 10500 provide an artificialbody wall with consistent properties compared with a natural body wall,for example, thickness, compliance, rigidity, uniformity, and the like.

The illustrated cap or cover 10500 is substantially circular. In otherembodiment, the gel cap 10500 has another shape or footprint, forexample, oval, elliptical, parabolic, square, rectangular, or anothersuitable curved or polygonal shape. In some embodiments, the outer ring6120 of the retractor and cap ring 10510 of the cap have the samegeneral shape or footprint. In other embodiments, the outer ring 6120 ofthe retractor and cap ring 10501 of the cap have substantially differentshapes, for example, a generally circular outer ring 6120 and an ovalcap ring 10510. In these embodiments, the outer ring 6120 is distortedor reshaped for coupling to the cap ring 10510, for example, bycompressing opposed sides of the outer ring 6120. Non-circular shapesare useful, for example, for procedures in which space is limited. Asdiscussed above, retracting a long, straight incision using an oval orelongated retractor requires less force than a similar procedure using acircular retractor.

In some embodiments, the pad 10530 comprises a gel. In such embodiments,the pad 10530 is referred to as a “gel pad” and the cap 10500 isreferred to as a “gel cap”. Descriptions of gel pads and gel capsgenerally apply to embodiments in which the pad 10530 does not comprisegel unless otherwise specified. In some embodiments, the gel pad 10530does not comprise any preformed access channels there through, forexample, for instrument access. Instruments may be inserted directlythrough the gel pad 10530, puncturing the gel pad 10530, and therebycreating access channels or portions in the gel pad 10530. Each accessportion forms an instrument seal in the presence of an instrumentinserted there through and a zero seal in the absence of an instrumentinserted there through. The gel provides a gas tight seal around avariety of shapes and sizes of instruments inserted there through. Someembodiments of the gel pad 10530 also provide trocar access directlythere through, which also provide instrument access into the bodycavity. Embodiments of the gel pad 10530 have a working diameter of fromabout 40 mm to about 120 mm, which is the diameter of a portion of thegel pad 10530 through which instruments and/or trocars may be inserted.Embodiments of the gel cap 10500 are typically from about 10 mm to 50 mmwider than the working diameter.

Accordingly, embodiments of the gel cap 10500 maintain pressurizationwithin a body cavity such as pneumoperitoneum or pneumorectum duringmultiple instrument exchanges and substantially prevent unintentionalloss of pressurization. Embodiments of the gel cap 10500 also providesubstantially continuous access and visibility during surgery.Embodiments of the gel cap 10500 have a small profile for use inprocedures with limited surgical space.

In some embodiments, the gel is an ultragel, which is characterized byan ultimate elongation greater than about 1000 percent and a durometerless than about 5 Shore A. Some embodiments of the ultragel comprisingKRATON® and mineral oil exhibit an ultimate elongation exceeding about1500 percent and improved sealing properties, for example, sealing withinstruments of a wider size range than other seal materials. In someembodiments, the seals comprising ultragels also form zero seals whenthe instrument is removed therefrom. Accordingly, in some embodiments ofseals comprising ultragels, a single seal is acts as both the instrumentseal as well as the zero seal.

Some embodiments of the cap ring 10510 comprise a substantiallycylindrical ring comprising a proximal portion, a distal portion, and alongitudinal axis extending from the proximal portion to distalportions. In other embodiments, the cap ring 10510 has another shape orfootprint, for example, oval. As best seen in FIG. 10B, which is abottom view of a cap ring 10510, in the illustrated embodiment, theproximal portion of the cap ring 10510 comprises a plurality ofapertures 10512 distributed about the periphery thereof. The apertures10512 extend through a wall 10514 at the proximal portion of the capring. In other embodiments, the apertures 10512 are disposed in at leastone member extending either longitudinally inward or longitudinallyoutward from the wall 10514 of the cap ring. The gel pad 10530 isdisposed at the proximal portion of the cap ring 10510 in theillustrated embodiment, with portions of the gel pad 10530 extendingthrough the apertures 10512, thereby creating an interlocking structurebetween the cap ring 10510 and the gel pad 10530, mechanically lockingthe cap ring 10510 and the gel pad 10530 together.

The distal portion of the cap ring 10510 is substantially cylindrical inthe illustrated embodiment, and is dimensioned and configured to receivethe outer ring 6120 (FIG. 5) of the wound retractor. The cap ring 10510comprises a latch mechanism 10516 that removably couples the cap ring10510 to the outer ring 6120. Those skilled in the art will understandthat other mechanisms are also useful for coupling the cap ring 10510 tothe outer ring 6120 of the wound retractor, for example, protrudinglips, levers, clips, latches, tongues, grooves, screw threads, bayonetmounts, screws, friction fittings, compression fitting, snap caps, andthe like. In the illustrated embodiment, when the outer ring 6120 of thewound retractor is received in the distal portion of the cap ring 10510,the outer ring 6120 of the wound retractor contacts and embeds within aportion of the gel pad 10530 disposed at the distal portion of the capring 10510, thereby displacing a portion of the gel, and forming a sealbetween the gel pad 10530, and the outer ring 6120 and tubular body 6130of the wound retractor. Thus, the distal portion of the gel pad 10530 isin juxtaposition with the incision or body orifice. In otherembodiments, the cap ring 10510 is permanently coupled or fixed to theouter ring 6120.

The cap ring 10510 in some embodiments comprises a polymer. Examples ofsuitable polymers include, at least one of polyethylene (PE), lowdensity polyethylene (LDPE), high density polyethylene (HDPE), ultrahigh molecular weight polyethylene (UHMWPE), polycarbonate,thermoplastic elastomers (DYNAFLEX®, GLS Corp.; KRATON®, KratonPolymers), polyphenylene oxide (PPO), polystyrene, and the like. Thepolymer component of the cap ring is fabricated by any suitable method,including injection molding, melt casting, blow molding, and the like.

Some embodiments of a process in which the gel pad 10530 is cast in thecap ring 10510 are include steps performed at temperatures above about130° C. over several hours, for example, from about three (3) to aboutfour (4) hours. Accordingly, in some of these embodiments, the cap ring10510 does not deform under these conditions.

Some embodiments of the gel pad 10530 comprise an elastomeric gel.Examples of such gels are described in U.S. patent application Ser. No.10/381,220, filed Mar. 20, 2003, the disclosure of which is herebyincorporated by reference as if set forth in full herein. Embodiments ofthe gel are prepared by mixing at least one triblock copolymer with asolvent that dissolves the midblocks of the triblock copolymer. Themixture is typically a slurry. The endblocks typically comprise athermoplastic material, such as styrene, while the midblocks typicallycomprise a thermoset elastomer such as, ethylene/butylene, isoprene, orbutadiene. Examples of the triblock copolymer includestyrene-ethylene/butylene-styrene (SEBS), styrene-isoprene-styrene(SIS), and styrene-butadiene-styrene (SBS). In some embodiments, thesolvent is an oil, for example, mineral oil. Upon heating a mixture orslurry of the triblock copolymer, the midblocks dissolve in the mineraloil, thereby forming a network of the insoluble endblocks. The resultingnetwork has enhanced elastomeric properties compared with the parentcopolymer. In some embodiments, the triblock copolymer used is KRATON®G1651, which has a styrene to rubber ratio of 33/67. Once formed, thegel is substantially permanent and, by the nature of the endblocks,processable as a thermoplastic elastomer henceforward. The mixture orslurry has a minimum temperature at which it becomes a gel, which isreferred to as the minimum gelling temperature (MGT). This temperaturetypically corresponds to the glass transition temperature of thethermoplastic endblock plus a few degrees. For example, the MGT for amixture of KRATON® G1651 and mineral oil is about 120° C. When theslurry reaches the MGT and the transformation to a gel state takesplace, the gel becomes more transparent, thereby providing a visualendpoint confirming the complete transformation of the slurry to the gelstate, whereupon the gel may be cooled. Some embodiments of the gelcomprise a diblock copolymer, either instead of or in addition to thetriblock copolymer. Embodiments of the diblock copolymer comprise athermoplastic first endblock, for example, styrene, and a thermosetelastomeric second endblock, for example, ethylene/butylene, isoprene,or butadiene. An example of a suitable diblock copolymer isstyrene-ethylene/butylene (SEB).

For a given mass of slurry to form a complete gel, the entire mass ofthe slurry is heated to or above the MGT and held at or above the MGTfor a sufficient time for the end blocks to form a network or matrix ofinterconnections. The slurry will continue to form a gel at temperaturesbetween the MGT and temperatures at which the components of theslurry/gel begin to decompose and/or oxidize. For example, when theslurry/gel is heated at temperatures above 250° C., the mineral oil inthe slurry/gel will begin to be volatile and oxidize. Oxidizing maycause the gel to turn brown and become oily.

The speed at which a given volume of slurry forms a gel depends on thespeed with which the entire mass of slurry reaches the MGT. Also, attemperatures higher than the MGT, the end block networks distribute andform more rapidly, thereby speeding the gel formation.

The various base gel formulas may also be mixed or alloyed with oneanother to provide gels with a variety of intermediate properties. Forexample, KRATON® G1701X is a mixture of seventy percent (70%) SEB andthirty percent (30%) SEBS, with an overall styrene to rubber ratio of28/72. Those skilled in the art will appreciate that an almost unlimitednumber of combinations, alloys, and styrene to rubber ratios can beformulated, each providing and embodiment exhibiting one or moreadvantages, for example, low durometer, high elongation, and good tearstrength.

Some embodiments of the gel material further comprise a polymer that,with a foaming agent, improves the sealing properties of the gel, forexample, silicone, soft urethanes, and even harder plastics. Examples ofsuitable silicones include those used for electronic encapsulation.Examples of suitable harder plastics include polyvinylchloride (PVC),isoprene, KRATON® neat, and other KRATON®/oil mixtures. In theKRATON®/oil mixture, suitable oils include vegetable oils, petroleumoils, and silicone oils, as well as mineral oil.

Some embodiments of the gel comprise one or more additives that provideone or more desirable properties, for example, at least one of enhancedlubricity, improved appearance, and wound protection. Additives areincorporated directly into the gel and/or applied as a surfacetreatment. In some embodiments, other compounds are added to the gel tomodify its physical properties and/or to assist in subsequentmodification of the surface by providing bonding sites and/or surfacecharges. Additionally, oil-based colorants are added to the slurry tocreate gels of different colors in some embodiments.

Some embodiments of the gel pad 10530 comprise a layer of polyethyleneon at least one surface. Polyethylene is dissolved in mineral oil andthe solution applied to one or more surfaces of the gel pad 10530. Themineral oil does not evaporate, but instead, absorbs into the gel padover time, leaving behind the polyethylene as a layer on the surface ofthe gel pad.

In some embodiments, the triblock copolymer/solvent mixture/slurry usedto manufacture the gel pad 10530 comprises about ninety percent (90%) byweight of mineral oil and about ten percent (10%) by weight of KRATON®G1651. From a thermodynamic standpoint, this mixture behaves similarlyto mineral oil. Because mineral oil has a relatively high heat capacity,transforming 0.45 kg (1 pound) of the slurry into a homogenous gel atabout 130° C. may take from bout three (3) to about four (4) hours. Onceformed, the gel can be cooled as quickly as practicable with no apparentdeleterious effects on the gel. In some embodiments, the gel is cooledby cold-water immersion. In other embodiments, the gel is air-cooled.Those skilled in the art will recognize that other cooling techniquesare used in other embodiments.

Certain properties of the KRATON®/oil gel will vary with the weightratio of the components. In general, a higher proportion of mineral oilresults in a softer gel, while a higher proportion of KRATON® results ina firmer gel. A too-soft gel exhibits excessive tenting or doming of thegel cap 10500 during surgery when a patient's body cavity isinsufflated. Some embodiments of gels that are too soft also do providean adequate instrument seal and/or zero seal. The gel should besufficiently soft to provide an adequate seal both in the presence of aninstrument and in the absence of an instrument, however.

On prolonged or extended sitting or standing, the copolymer, such asKRATON®, and the solvent, such as mineral oil, in the slurry mayseparate. The slurry may be mixed to greater homogeneity, for example,with a high shear mixer. Mixing the slurry may introduce or add air tothe slurry, however. To remove air from the slurry, the slurry may bedegassed. In some embodiments, the slurry is degassed under a vacuum,for example, within a vacuum chamber. In some embodiments, the appliedvacuum is about 0.79 meters (about 29.9 inches) of mercury, or about one(1) atmosphere. Optionally, stirring or mixing the slurry under vacuumfacilitates removal of the air. During degassing under vacuum, theslurry typically expands, then bubbles, and then reduces in volume. Thevacuum is typically discontinued when the bubbling substantially ceases.Degassing the slurry in a vacuum chamber reduces the volume of theslurry by about ten percent (10%). Degassing the slurry also reducesoxidation of the finished gel in some embodiments.

Degassing the slurry tends to result in a firmer gel. A gel made from adegassed slurry comprising about 91.6% by weight of mineral oil andabout 8.4% by weight of KRATON® G1651, an eleven-to-one ratio, has aboutthe same firmness as a gel made from a slurry that is not degassed andthat comprises about ninety percent (90%) by weight of mineral oil andabout ten percent (10%) by weight of KRATON® G1651, a nine-to-one ratio.

Because mineral oil typically has a lower density than KRATON®, the twocomponents will separate after mixing, with the less dense mineral oilrising to the top of the container. This phase separation typicallyoccurs when transforming a static slurry into a gel over several hours.Consequently, the resulting gel is non-homogeneous, with a higherconcentration of mineral oil at the top and a lower concentration at thebottom. The speed of separation is a function of the depth or headheight of the slurry being heated. Factors relevant to the relativehomogeneity of the gel include the mass of slurry, the head height, thetemperature at which the gel sets, and the speed at which the energy istransferred to the gel.

The gel pad 10530 or gel cap 10500 are gamma sterilized in someembodiments, which is relatively and/or comparatively simpler to qualifycompared with other sterilization process, for example, versus ethyleneoxide. Gamma sterilization can cause large bubbles to form in the gelpad, however, which are cosmetic and/or aesthetic issues in thesterilized devices. Because bubbles typically comprise greater thanninety-nine percent (99%) room air, the dissolved air is advantageouslyremoved from the slurry prior to transforming the slurry into a gel. Forexample, the slurry may be degassed under vacuum, as described above,then gelled by heating. Some bubbles may still form in the gel duringgamma sterilization, but typically disappear over a period of from abouttwenty-four (24) hours to about seventy-two (72) hours. Typically,mineral oil at room temperature has about ten percent (10%) dissolvedgas. As discussed above, removing air from the gel makes the gel firmer.This effect is counterbalanced by a softening of the gel by the gammaradiation during gamma sterilization, however.

In some embodiments in which the gel pad 10530 is gamma sterilized, thegel comprises about ninety percent (90%) mineral oil by weight and aboutten percent (10%) KRATON® by weight. As stated above, degassing theslurry makes the gel firmer. The counteracting softening by the gammaradiation, however, results in a gel with substantially the samefirmness as a gel comprising about ninety percent (90%) mineral oil byweight and about ten percent (10%) KRATON® by weight that is notdegassed and gamma sterilized.

In some embodiments, the gel pad 10530 is coupled to, attached to,formed with, or integrated with the cap ring 10510 to provide agas-tight seal between the cap ring 10510 and the tubular body 6130(FIG. 5). The gel pad 10530 covers and seals the entire opening in thecap ring 10510, as well as covering substantially the entire wound ororifice opening. As stated above, the gel pad 10530 provides a gas tightseal around a variety of shapes and sizes of instruments inserted therethrough.

Embodiments in which a gel pad support structure of the cap ring 10510comprises a thermoplastic elastomer, for example, DYNAFLEX® or KRATON®,and the gel pad 10530 comprises a similar thermoplastic elastomer, forexample, KRATON®, exhibit improved adhesion between the gel pad 10530and the cap ring 10510. The polystyrene component of KRATON® in the gelpad 10530 improves adhesion with polyphenylene oxide (PPO), polystyrene,and other similar polymers.

In some embodiments of cap rings 10510 comprising polycarbonate, thepolycarbonate component of the cap ring 10510 does not bond with the gelpad 10530 at 130° C., which is a typical manufacturing temperature for agel pad 10530 comprising KRATON®. Raising the temperature to about 150°C. for a few minutes during casting, however, bonds the gel pad 10530 tothe cap ring 10510. It is believed that heating the gel pad 10530 andcap ring 10510 to a temperature at which both the polystyrene componentof the gel and the polycarbonate are simultaneously above their meltpoints allows bonds to form there between. In other embodiments, theuncured gel and the cap ring 10510 are heated to near or at the glasstransition temperature of the polycarbonate in the cap ring 10510,thereby bonding the gel pad 10530 to the cap ring 10510.

In some embodiments, the gel comprises mineral oil and the cap ring10510 comprises a polymer that dissolves in mineral oil under themanufacturing conditions, for example, polyethylene (PE), low densitypolyethylene (LDPE), high density polyethylene (HDPE), and ultra highmolecular weight polyethylene (UHMWPE). Using polyethylene (PE) as anexample, PE has a higher molecular weight than mineral oil and dissolvesin mineral oil at the temperatures used to cast the gel pad 10530. Assuch, as a portion of the PE in the cap ring 10510 dissolves in themineral oil in the gel pad 10530 at the processing temperatures, forexample, above about 130° C., a bond between the PE in the cap ring10510 and gel pad 10530 is formed.

In an embodiment of a method for manufacturing a gel cap, the cap ring10510 is placed into a mold that together with the cap ring 10510includes a negative space in the desired shape of the gel pad anduncured gel is added to the mold. Sufficient uncured gel is then addedto the mold to cover and fill the apertures 10512. The uncured gel flowsthrough, fills, and remains within the apertures. Also, in someembodiments, the mold is filled with sufficient uncured gel to extendinto the distal portion of the cap ring 10510. After the gel cures, thegel in the apertures connects and couples the gel on a first side ofeach aperture 10512 to the gel on a second side of the aperture, therebymechanically locking the gel pad 10530 to the cap ring 10510.

Some embodiments include another method for coupling the gel pad 10530to the cap ring 10510, either in addition to or instead of themechanical interlocking discussed above. Such methods are useful, forexample, for coupling separately formed gel pads or gel slugs 10530 andcap rings 10510. Some embodiments use a glue or adhesive to couple thegel pad 10530 to the cap ring 10510, for example, cyanoacrylate(SUPERGLUE® or KRAZY GLUE®). The glue is believed to bond to either therubber or the styrene component of the triblock copolymer with a bond isfrequently stronger than the gel material itself. Some embodiments usesolvent welding in which a solvent dissolves a plastic in the cap ring10510 and the polystyrene in the gel pad 10530. The solvent is appliedto the gel pad 10530 and cap ring 10510 by any suitable method, forexample, by spraying and/or by dipping. In effect, the solvent meltsboth the plastic of the cap ring 10510 as well as the polystyrene in thegel pad 10530, thereby forming a bond between the two, which remainsafter the solvent evaporates.

In an embodiment for manufacturing a gel cap 10500, the gel pad 10530 iscast into the cap ring 10510 to form the gel cap 10500. The cap ring10510 is positioned in or placed into a mold cavity of a casting mold.Embodiments of the mold cavity include support for the annular walls ofthe cap ring 10510. Embodiments of the mold comprise a material withsufficient heat dissipation properties, for example, at least one ofaluminum, copper, and brass. Those skilled in the art will recognizethat other mold materials with lower heat dissipation properties willproduce acceptable parts in some embodiments. Furthermore, someembodiments of the mold comprise active cooling elements, for examples,channels through which coolants are pumped.

The mold cavity and cap ring 10510 assembly is then filled with adesired amount of the triblock copolymer/mineral oil slurry such thatthe slurry contacts the cap ring 10510. In some embodiments, the slurryis preheated, for example, to about 52° C. (125° F.), which facilitatesa complete filling of the mold cavity by the slurry, thereby reducingthe probability of voids in the gel. Preheating the slurry to atemperature below the MGT reduces the viscosity of the slurry and allowsthe slurry to flow more easily. As stated above, some embodiments of theslurry are degassed in a vacuum before casting. In some embodiments, theslurry is also degassed after it is filled in the mold cavity to removeany air that may have been introduced during the filling of the moldcavity, as well as to facilitate flow of the slurry into voids in themold. The mold, cap ring, and slurry are heated, for example, in anoven, until the slurry reaches a temperature of about 150° C. As statedabove, the slurry turns into gel at about 120° C.; however, at about150° C., the gel bonds to a polycarbonate cap ring 10510. Depending onthe material used in the cap ring 10510, bonding may take place at atemperature other than about 150° C. In embodiments in which the capring 10510 is comprises a material with a lower melting point than theMGT, for example 120° C., the gel pad 10530 is molded separately as agel slug, which is then bonded to the cap ring 10510 as discussed above.

When the transformation of the slurry into a gel is complete, forexample, when the temperature of the gel pad reaches about 150° C., thegel cap 10500 is cooled, for example, by air-cooling, cold-waterimmersion, or another suitable method. At 150° C. the gel pad 10530 issoft and easily distorted. Distortions in the gel pad 10530 presentduring cooling would be set after cooling. Accordingly, in someembodiments, the gel cap 10500 is cooled within the mold, therebyreducing the likelihood of distorting the gel pad 10530. Factorsaffecting the cooling time include the size and configuration of themold, the quantity of gel, temperature and quantity of cooling medium,the properties of the cooling medium, and the mold material. As anexample, the cooling time for a particular gel cap 10500 may be abouttwo (2) hours for air cooling and about fifteen (15) minutes for watercooling. Whether cooling with air or water, the final properties of thegel are substantially the same. The gel cap 10500 is typically cooled toabout ambient room temperature, but may be cooled to a lower temperatureif desired. At about 0° C., the gel hardens, which is useful, forexample, in secondary operations such as when coupling separatelymanufactured gel pads 10530 and cap rings 10510. The gel cap 10500 maybe removed from the mold at any time after the gel has set.

When removed from the mold, the gel pad 10530 typically has a tackysurface. Coating the gel pad 10530 with a powder, such as cornstarch,substantially reduces or eliminates the tackiness of the cured gel pad10530.

As stated above, in some embodiments, the gel pad 10530 is moldedseparately from the cap ring 10510, and coupled to the cap ring 10510 ina secondary operation, for example, bonding. In some embodiments, thegel pad 10530 is molded as a gel slug with an outer perimeter smallerthan the perimeter of the inner cylindrical wall of the cap ring 10510and a height greater than the height of the cap ring 10510. Because thegel pad 10530 is molded separate from the cap ring 10510, the slurryneed only be heated to the MGT, for example, about 120° C., to completethe transformation of the slurry into a gel, whereupon the gel becomessubstantially transparent. As discussed above, the gel slug may becooled, for example, to about 0° C., then placed within the innercylindrical wall of the cap ring 10510.

In some embodiments, the gel slug is coupled to the cap ring 10510through compression molding, in which the gel slug is compressedlongitudinally, thereby expanding the outer perimeter of the gel slugand compressing the gel slug against the inner cylindrical wall of thecap ring 10510. The compressed gel slug and cap ring 10510 are thenheated to a sufficient temperature for the polystyrene in the gel andthe polymer of the cap ring 10510 to form bonds there between. Moldingthe gel slug separately from the cap ring 10510 followed by heat bondingthe gel slug to the cap ring is especially useful in embodiments inwhich the cap ring 10510 comprises a material with a melting temperaturelower than the MGT of the gel. In such situations, the gel slug can bemolded separately and heat bonded to the cap ring 10510 without meltingthe cap ring 10510.

An embodiment of a method for retracting an incision or body orificeusing the retractor 6100, 7100 is discussed in detail above. The methodresults in the outer ring 6120 of the retractor substantially in contactwith the exterior surface of the body wall. The gel cap 10510 is thencoupled to the outer ring 6120 of the retractor, thereby sealing theopening between the body cavity and the area outside the body cavity andallowing the surgeon to insufflate the body cavity.

As discussed above, embodiments of the gel cap 10500 comprise nopreformed access channels in the gel pad 10530. In use, instruments maybe inserted directly through the gel pad 10530, thereby creating accesschannels through the gel pad 10530. Each access channel created in thegel cap forms an instrument seal in the presence of an instrumentpassing there through because the gel provides a gas tight seal around avariety of shapes and sizes of instruments. When the instrument isremoved from the gel pad 10530, the channel created in the gel pad bythe instrument closes to form a zero seal.

Some embodiments of the cap use access devices such as trocars insertedthrough the gel pad 10530 for instrument access, in particular, where anaccess channel experiences repeated instrument manipulation, forexample, insertion, removal, advancement, retraction, rotation and/orother manipulation. Each trocar inserted through the gel pad 10530permits repeated introduction, removal, and/or manipulation ofinstruments there through.

In some embodiments, the gel cap 10500 initially comprises no accesschannels, and the surgeon is at liberty to determine the placement ofinstruments there through. Moreover, the surgeon has unlimitedflexibility in the placement and repositioning of ports within the areaof the gel cap 10500, as well as the option of selecting differenttrocar sizes for different clinical procedures. Being detachable, thegel cap 10500 allows for the removal of large specimens. Once removed,the gel cap 10500 can be re-coupled to the outer ring 6120 of theretractor, thereby restoring the seal and allow the surgeon tore-insufflate the body cavity.

Moreover, embodiments of the gel are deformable without losing physicalintegrity, and while maintaining substantially gas tight instrumentseals with any instruments extending there through, as well as gas tightzero seals for any access channels without any instruments extendingthere through. Accordingly, embodiments of the gel cap 10500 permit bothtranslational or positional, and angular or pivotal “float” or degreesof freedom for the instruments passing through the gel pad 10530. Thisfloat permits instrument motion both relative to the cap ring 10510 aswell as relative to other instruments. In contrast, other single orlimited port systems do not exhibit one or both translational or angularfloat for instruments.

FIG. 11A is a top view of an embodiment of a gel cap 11500 comprising aplurality of access ports, seals, or sealing valves disposed in the gelpad. FIG. 11B is a perspective top view of the gel cap 11500 mounted ona retractor. FIG. 11C is a perspective bottom view of the gel cap 11500mounted on a retractor. The gel cap 11500 comprises a cap ring 11510 anda gel pad 11530, which are generally similar to the cap ring and gel padof the embodiment described above.

The gel cap 11500 further comprises a plurality of access ports 11540,at least a portion of which is disposed within or embedded within thegel pad 11530. In the illustrated embodiment, the access ports 11540have a low profile, that is, do not protrude or protrude minimally abovethe proximal surface of the gel pad 11530 and/or below the distalsurface of the gel pad 11530. Accordingly, the lengths of the accessports 11540 are similar to the thickness of the gel pad 11530, which isshorter than a length of a typical trocar inserted in the gel pad 11530,which comprises a seal assembly positioned above the gel pad 10530, anda cannula extending through the gel pad 11530. The reduced length of theaccess port 11540 allows increased angular or pivotal motion forinstruments extending there through, and also permits the use of curvedand/or angled instruments. In the illustrated embodiment, the accessports 11540 are substantially permanent or non-removable under theconditions under which the gel cap 11500 is used. Trocars can also beinserted through the gel pad 11530 if additional ports are desired.

Each port 11540 comprises longitudinal axis extending from a proximalside to a distal side of the gel pad 11530, a first seal 11542 disposedat the proximal side of the gel pad 11530, and a second seal 11544disposed distal to the first seal 11542. A sight of each of the ports orseals 11540 has an aperture through the gel pad 11530 and coincides withthe longitudinal axis. In the illustrated embodiment, the first seal11542 forms an instrument seal with an instrument extending therethrough and the second seal 11544 forms a zero seal in the absence of aninstrument extending there through.

In the illustrated embodiment, the first seal 11542 comprises a septumseal. Each septum seal comprises an aperture 11546 there through that isslightly smaller than a cross-section of the smallest instrument to beinserted there through. The aperture 11546 of the septum seal issubstantially aligned with the aperture through the gel pad and thelongitudinal axis of the port 11540. When an instrument is insertedthrough the aperture 11546 of the septum seal, the aperture 11546expands and engages the outer surface of the instrument, thereby forminga seal therewith. The septum seal comprises an elastomeric material thatbiases the aperture against an instrument is inserted there through.Those skilled in the art will understand that other types of instrumentseals are used in other embodiments.

In the illustrated embodiment, the second seal 11544 comprises adouble-duckbill valve, which functions as a zero-closure seal thatprovides a zero seal in the absence of an instrument inserted therethrough. Those skilled in the art will understand that the second sealcomprises another type of seal, for example, a duckbill valve, a flapvalve, and the like. The double-duckbill valve comprises as elastomericmaterial. In some embodiments, each of the first seal 11542 and thesecond seal 11544 independently comprise an elastomeric material, forexample, at least one of rubber, synthetic rubber, silicone, ethylenepropylene diene monomer (EPDM), ethylene-propylene copolymer (EPrubber), polyisoprene, polybutadiene, polyurethane, styrene-butadiene,ethylene vinyl acetate (EVA), polychloroprene (NEOPRENE®),perfluorelastomer (KALREZ®), and the like

Thus, during use, the septum seal provides an instrument seal in thepresence of an instrument inserted there through, and the duckbill valveprovides a zero seal in the absence of an instrument inserted therethrough. The illustrated embodiment comprises ports or seals 11540 inthe gel pad of different sizes. Each size of port 11540 sealingaccommodates a different range of instrument sizes inserted therethrough. The size of a port is typically given as the diameter of thelargest instrument that the port will accommodate, for example, 5 mm, 11mm, or 12 mm. FIGS. 11D, 11E, and 11F are a perspective top view, aperspective bottom view, and a side view of a thinner instrument 11550 aand a thicker instrument 11550 b inserted through a smaller port 11540 aand a larger port 11540 b, respectively, of the embodiment of the gelcap 11500 illustrated in FIGS. 11A-11C.

FIG. 11G is a top perspective view of an embodiment of a gel cap 11500further comprising a fixed port position, for example, for a camera or alaparoscope. The fixed port 11560 comprises a lock mechanism 11562 thatmaintaining the position of a camera or laparoscope inserted therethrough. In some embodiments, one of the ports 11540 further comprises astopcock and/or gas fitting used as a gas inlet and/or outlet port forinsufflating, depressurizing, and/or venting the body cavity of gas. Insome embodiments, a gas inlet/outlet port is disposed on the cap ring11510.

FIG. 12 is a cutaway perspective view of an embodiment of an accessdevice system 12000 comprising retractor 12100 and a cap or cover 12500,which are similar to embodiments of retractors and gel caps describedabove. The retractor 12100 comprises an inner ring 12110, an outer ring12120, and a sleeve 12130 extending between the inner ring 12110 and theouter ring 12120. In the illustrated embodiment, the cap 12500 is a gelcap comprising a proximal side, a distal side, a cap ring 12510, and agel pad 12530. In the illustrated embodiment, the cap ring 12510comprises a tubular ring dimensioned to receive the outer ring 12120 ofthe retractor therewithin. The distal side of the cap ring 12510comprises an annular slot 12520, which is sufficiently radiallydeformable for the outer ring 12120 to reversibly pass there through.Accordingly, the illustrated embodiment of the cap ring 12510 securesthe cap 12500 to the outer ring 12120 with a snap or friction fit.

FIG. 13 is an exploded view of an embodiment of a trocar 13800 andoptional obturator 13900, which is a component of some embodiments ofthe access device system. In the illustrated embodiment, the obturator13900 comprises a pointed, puncture tip 13910. In embodiments in whichthe trocar 13800 and obturator 13900 are inserted through a gel pad10530 rather than a body wall, potential damage to underlying tissue bycontact with the tip 13910 is reduced because the gel pad 10530 servesas an artificial body wall that is spaced from the underlying tissue asdiscussed above. In other embodiments, the obturator tip 13910 hasanother shape, for example, blunt and/or bladeless, which, for example,reduces the likelihood of damage to other components of the accesssystem, for example, a retraction sheath of a retractor.

The trocar 13800 comprises a proximal end, a distal end, and alongitudinal axis. The trocar 13800 comprises a cannula 13810 extendingalong the longitudinal axis. A trocar seal 13820 is disposed at theproximal end of the cannula 13810. A retainer 13830 is disposed at thedistal end or tip of the cannula 13810. In the illustrated embodiment,the distal end or tip of the cannula 13810 is not angled. Otherembodiments comprise an angled distal end or tip of the cannula 13810.The illustrated embodiment of the trocar 13800 does not comprise aninsufflation gas inlet. Consequently, the trocar 13800 is typically usedin procedures in which a body cavity is not insufflated, or in whichinsufflation is provided through another device. Other embodiments oftrocars are disclosed in U.S. patent application Ser. No. 11/677,994,filed Feb. 22, 2007, the disclosure of which is incorporated byreference.

The cannula 13810 comprises an elongate, tubular cannula body 13812dimensioned to accommodate an instrument or instruments received therethrough. In the illustrated embodiment, the cannula body 13812 is asubstantially cylindrical tube, and extends through the gel pad 10530 inuse. In the illustrated embodiment, the cannula body 13812 extends fromthe proximal end of the cannula 13810 to which the trocar seal 13820 iscoupled, and which has a larger outer diameter than the cannula body13812.

In some embodiments, the cannula 13810 is comparatively short becausethe cannula body 13812 need only traverse the gel pad 10530 (FIG. 10A),which has a known and consistent thickness, rather than a body wall.Accordingly, some embodiments of the cannula body 13812 are not morethan about 2-times longer, about 1.5-times longer, about 1.2-timeslonger, or about 1.1-times longer than the thickness of the gel pad. Insome embodiments, the cannula body 13812 is less than about 20 mm, about10 mm, or about 5 mm longer than the thickness of the gel pad. In someembodiments, the cannula body 13812 is about as long as the gel pad isthick. In other embodiments, the cannula body 13812 has a differentlength, for example, a length typical for a cannula used for traversinga body wall. Shorter length cannula bodies permit increased angulardegrees of freedom for instruments passing there through. Embodiments ofshorter cannula bodies also accommodate curved instruments. The cannula13810 comprises any suitable biocompatible material. In someembodiments, the cannula 13810 comprises a flexible material.

The illustrated trocar seal 13820 comprises an instrument or septum seal13822 and a zero seal 13824. The instrument seal 13822 seals instrumentspassing there through, thereby maintaining pressurization in a bodycavity such as pneumoperitoneum or pneumorectum. The zero seal 13824provides a seal when no instrument passes through the trocar seal 13820.The instrument seal 13822 and zero seal 13824 are received in a housing13826 disposed at the proximal end of the cannula 13810 and securedtherein by a seal cover 13828.

The retainer 13830 is disposed at or near the distal end of the cannula13810. In the illustrated embodiment, the distal end of the cannula13810 is generally perpendicular to the longitudinal axis thereof, ornot angled. Other embodiments comprise an angled distal end or tip. Insome embodiments, the retainer 13830 and cannula 13810 are integrated,while in other embodiments, the retainer 13830 and cannula 13810 are notintegrated. In the illustrated embodiment, the proximal end of theretainer 13830 comprises a flange 13832 that is generally flat andperpendicular to the longitudinal axis, while the distal end is tapered,narrowing toward the distal end of the cannula 13810. The flange 13832reduces the likelihood of accidental or inadvertent removal of thetrocar 13800 from the gel pad. Some embodiments of the proximal face ofthe flange 13832 comprise additional anchoring features, for example, atleast one of barbs, spikes, ridges, texturing, and the like, which areconfigured to penetrate or bite into a distal face of the gel pad 10530.In some embodiments, a diameter of the flange 13832 is from about 1.5 toabout 2.5 times wider, or from about 2 to about 2.2 times wider than anouter diameter of the cannula body 13812. Some embodiments of the trocar13800 are 5-mm trocars, in which the outer diameter of the cannula body13812 is from about 7 mm to about 8 mm.

The tapered end of the retainer 13830 facilitates insertion of thetrocar 13800 through the gel pad, either by itself, or when assembledwith the obturator 13900 extending there through. For example, in someembodiments, the retainer 13830 is inserted through a preformed openingin the gel pad 10530. Because embodiments of the gel material of the gelpad 10530 have high elongation values, as discussed above, the retainer13830 is insertable through a relatively small opening in the gel pad10530, yet resists inadvertent removal, as discussed above.

In some embodiments in which the retainer 13830 and cannula 13810 arenot integrated, that is, are separate components, the retainer 13830 issecured to the cannula 13810 after the cannula 13810 is inserted throughthe gel pad. In some embodiments, the cannula 13810 and retainer 13830are secured mechanically, for example, using latches, screw threads,clips, lock rings, ratchets, and the like. In some embodiments, thecannula 13810 and retainer 13830 are secured adhesively. In someembodiments, the position of the retainer 13830 is adjustable, forexample, to accommodate gel pads of different thicknesses. In someembodiments, the cannula 13810 and/or retainer 13830 is secured to thegel pad, for example, adhesively.

FIG. 14A is a side view of another embodiment of a trocar 14800 that issuitable as a component of a single-port surgical access systemdescribed above, for example, comprising a gel pad 10530 and retractor.Some embodiments of the access system comprise a plurality of trocars14800. The trocar 14800 is generally similar to the trocar 13800described above, and comprises a cannula 14810, a trocar seal assembly14820, and a retainer 14830, which are generally similar to thecorresponding features described above. The illustrated embodiment ofthe trocar 14800 further comprises a bolster 14840 and a lockingcomponent 14850. The illustrated embodiment of the cannula 14810 is alsoreferred to as a “fixation cannula” as will become apparent from thediscussion below.

In the illustrated embodiment, the bolster 14840 comprises a torus ordoughnut. A cannula body 14812 extends through an opening in the bolster14840. A diameter of the opening of the bolster 14840 is sufficientlylarger than an outer diameter of the cannula body 14812 to permit freemovement along the cannula body 14812. The illustrated embodiment of thebolster 14840 comprises a deformable material, for example, a polymerresin and/or elastomer, as will be described in greater detail below.Examples of suitable materials include rubber, natural rubber, syntheticrubber, polyisoprene, styrene-butadiene rubber, silicone rubber,ethylene-propylene copolymer, ethylene-propylene-diene monomer rubber,polybutadiene, polychloroprene, polyurethane, and the like. Someembodiments of the bolster 14840 comprise a lubricious layer or coatingin an area or region that contacts the cannula 14810, which facilitatesmovement along the cannula 14810.

An outer diameter of some embodiments of the bolster 14840 is from about0.8 to about 2 times, or from about 1 to about 1.5 times a diameter of aflange 14832 of the retainer 14830. A thickness of the bolster is fromabout 3 mm (0.12 inch) to about 10 mm (0.4 inch), or from about 4 mm(0.16 inch) to about 6 mm (0.24 inch). In some embodiments, a distalface 14844 of the bolster is concave, thereby providing additionalclamping or fixation force on the gel pad 10530, as well as conformingto gel pads 10530 with different and/or non-uniform thicknesses. Theparticular dimensions of the bolster 14830 are selected based on theproperties of the bolster material and the gel material, and thedimensions of the cannula body 14812, the locking component 14850, andthe gel pad 10530.

The locking component 14850 is disposed on the cannula body 14812proximal of the retainer 14830, and comprises a lip 14852 proximal of anenlarged section 14854. The lip 14852 extends radially from the cannulabody 14812 with a diameter greater than the diameter of the opening ofthe bolster 14840. The elastomeric material of the bolster 14840 permitsthe bolster 14840 to be urged over and past the lip 14852. In theillustrated embodiment, the lip 14852 comprises a ratchet dimensioned tofacilitate the bolster 14840 sliding distally and to resist the bolster14840 from sliding proximally. Also, in the illustrated embodiment, thelip 14852 is a continuous structure encircling the cannula body 14812.In other embodiments, the lip 14852 comprises a plurality of structuresdisposed around the cannula body 14812.

The enlarged section 14854 is generally cylindrical with a diameter thatis about the same as or slightly larger than the diameter of the openingin the bolster 14840, thereby frictionally engaging the bolster 14840thereto. In the illustrated embodiment, the enlarged section 14854 islonger than a thickness of the bolster 14840. In the illustratedembodiment, the enlarged section 14854 does not extend to or contact theflange 14832 of the retainer 14830, thereby not reducing a surface areaof a proximal face thereof, and thereby improving the removal resistancethereof. In other embodiments, the enlarged section 14854 extends to theretainer 14830. Other embodiments do not comprise an enlarged section.

A distance between a distal end of the lip 14852 and a proximal face ofthe flange 14832 is equal to or slightly less than a sum of a thicknessof the bolster 14840 and the gel pad 10530. In some embodiments, the gelpad is from about 5 mm (about 0.4 inch) to about 30 mm (about 1.2 inch)thick, or from about 13 mm (about 0.5 inch) to about 25 mm (about 1inch) thick.

The trocar 14800 has at least two configurations: a first or insertionconfiguration illustrated in FIG. 14A, and a second or fixationconfiguration illustrated in FIG. 14B.

In an embodiment of a method for using the trocar 14800, the trocar14800 is placed in the insertion configuration in which the bolster14840 is first positioned on the cannula body 14812. The trocar 14800 isplaced in the artificial body wall either before the artificial bodywall is coupled to a patient's body and/or after coupling thereto.

In the embodiment illustrated in FIG. 14A, the bolster 14840 ispositioned at the proximal end of the cannula body 14812, where thebolster 14840 frictionally engages a distal portion of a cannula bell14814, which is an enlarged portion at the proximal end of the cannula14810 to which the seal assembly 14820 couples.

The distal end of the trocar 14800 is positioned on, then the retainer14830 inserted through an artificial body wall, for example, a gel pad10530. In some embodiments, an obturator 13900 (FIG. 13) is firstinserted through the seal assembly 14820 at the proximal end of thetrocar with the tip 13910 extending from the distal end thereof beforethis step. In other embodiments, an opening is first made in theartificial body wall using another instrument. In other embodiments, thedistal end of the trocar 14800 is forced through the artificial bodywall, generating an opening in the process.

The trocar 14800 is then converted into the fixation configurationillustrated in FIG. 14B by sliding the bolster 14840 down the cannulabody 14812, and over the lip 14852 onto the enlarged section 14852. Inthe illustrated configuration, the artificial body wall is captured andcompressed between the flange 14830 of the retainer and the bolster14840. The lip 14852 locks the bolster 14840 in place, preventing itfrom moving proximally, thereby fixing or locking the trocar 14800 tothe artificial body wall.

In the fixation configuration, the trocar 14800 fixed relative to alocal portion of the artificial body wall to which it is engaged. Asdiscussed above, however, embodiments of artificial body walls exhibithigh elongations. Accordingly, the trocar 14800 is translatable and/orpivotable relative to an original position and orientation by deformingthe artificial body wall.

In embodiments using an obturator 13910, the obturator is withdrawn. Thetrocar 14800 serves as an access port for one or more instruments duringa surgical procedure.

If desired, the trocar 14800 is removed from the artificial body wall,for example, by first disengaging the bolster 14840 from the lockingcomponent 14850, then pulling the retainer 14830 from the artificialbody wall. In some embodiments, the trocar 14800 and artificial bodywall are not disengaged and are disposed of as a unit. In someembodiments, the bolster 14840 is not disengagable from the lockingcomponent 14850.

FIG. 15 is a side view of another embodiment of a retention trocar15000, which is generally similar to the embodiment illustrated in FIGS.14A and 14B and described above. The trocar 15000 comprises an elongate,tubular cannula 15810 comprising a proximal end, a distal end, and acannula body 15812; a seal assembly 15820 coupled to the proximal end ofthe cannula 15810; a retainer 15830 disposed at the distal end of thecannula 15810; a bolster 14840 through which the cannula body 15812extends; and a locking component 15850 disposed on the cannula bodyproximal of the retainer 15830.

In the illustrated embodiment, the locking component 15850 comprises anenlarged section 15854 on which are disposed screw threads 15852. Thebolster 15840 comprises matching threads. Consequently, the bolster15840 is threadably engagable to the locking component 15850. Thethreading also permits adjusting the relative positions of the bolster15840 and a flange 15832 of the retainer in the fixation configurationof the trocar 15800, thereby permitting fixation to an artificial bodywall with a non-uniform thickness and/or to artificial body walls ofdifferent thicknesses.

FIG. 16A is a side view of another embodiment of a trocar 16800. FIG.16B is a perspective view of an embodiment of a bolster 16840 usablewith the trocar 16800. The combination of the trocar 16800 and bolster16840 are generally similar to the embodiments of trocars illustrated inFIGS. 14A, 14B, and 15. The trocar 16800 comprises an elongate, tubularfixation cannula 16810 comprising a proximal end, a distal end, and acannula body 16812; a seal assembly 16820 coupled to the proximal end ofthe cannula 16810; a retainer 16830 disposed at the distal end of thecannula 16810; and a locking component 16850 disposed on the cannulabody proximal of the retainer 16830.

In the illustrated embodiment, the locking component 16850 comprises anenlarged section 16854 comprising a plurality of annular rings 16852extending radially from the cannula body 16812, which define a pluralityof annular slots 16856. In the illustrated embodiment, a proximal edgeof each ring 16856 is beveled; however, some embodiments do not comprisea beveled edge.

FIG. 16B illustrates an embodiment of a bolster 16840 in the form of aclip comprising a flattened body 16842 comprising a cut-out 16844comprising a semicircular portion. The cut-out 16844 is dimensioned toengage the slots 16856. A thickness of the body 16842 at the cut-out16844 is also dimensioned to engage the slots 16856. The bolster 16840comprises a grip 16846 extending vertically from the body 16842, whichprovides a user grip for installing and/or adjusting the bolster 16840.In other embodiments, the cut-out 16844 has another shape, for example,polygonal, rectangular, a portion of a hexagon, and the like.

In use, the retainer 16830 of the trocar is inserted through anartificial body wall as discussed above, and fixed therein by engagingthe bolster 16840 in a slot 16856 providing a desired fixation force.The degree of fixation is adjustable by selecting a different slot.

In some embodiments, the bolster cut-out 16844 engages a plurality ofslots, thereby providing additional stability in the fixationconfiguration. Other embodiments comprise a bolster through with thecannula body 16812 extends, similar to the embodiments discussed above.In some of these embodiments, the locking component 16850 serves as aratchet. The bolster comprises one or more pawls, which are optionallydisengagable, thereby enhancing adjustability.

FIG. 17A illustrates a side view of an embodiment of a trocar 17800comprising a fixation cannula and FIG. 17B is a perspective view of anembodiment of a bolster. The embodiments illustrated in FIGS. 17A and17B are generally similar to the embodiments of trocars illustrated inFIGS. 14A-16B and described above.

The trocar 17800 comprises an elongate, tubular fixation cannula 17810comprising a proximal end, a distal end, and a cannula body 17812; aseal assembly 17820 coupled to the proximal end of the cannula 17810; aretainer 17830 disposed on the cannula body 17812; and a lockingcomponent 17850 disposed at the distal end of the cannula 17810. Theillustrated embodiment of the trocar 17800 is similar to the embodimentillustrated in FIG. 16A with the positions of the retainer 17830 and thelocking component 17850 reversed. In the illustrated embodiment, aflange 17832 of the retainer faces distally.

The locking component 17850 comprises an enlarged section 17854comprising a plurality of annular rings 17852 extending radially fromthe cannula body 17812, which define a plurality of annular slots 17856.

FIG. 17B illustrates an embodiment of a bolster 17840 in the form of aclip comprising a flattened body 17842 comprising a cut-out 17844comprising a semicircular portion. The cut-out 17844 is dimensioned toengage slots 17856 in the locking component. A thickness of the body17842 at the cut-out 17844 is also dimensioned to engage the slots17856. The illustrated embodiment of the bolster does not comprise agrip; however, other embodiments comprise a grip.

In some embodiments for using the embodiment of the trocar 17800, thecannula 17810 is fixed to an artificial body wall before the artificialbody wall is coupled to a patient's body. For example, in someembodiments, one or more trocars 17800 are fixed on a gel pad 10530(FIG. 10A) of a gel cap 10500 before the gel cap 10500 is coupled to aretractor 6100.

While certain embodiments have been particularly shown and describedwith reference to exemplary embodiments thereof, it will be understoodby those of ordinary skill in the art that various changes in form anddetails may be made therein without departing from the spirit and scopethereof as defined by the following claims.

What is claimed is:
 1. A surgical access port system adapted forperforming surgical procedures at a natural orifice comprising: an outerring, wherein the outer ring is configured to be disposed proximate thenatural orifice of a patient; a tubular body having a longitudinal axis,a proximal end and a distal end, wherein the proximal end of the tubularbody is coupled to the outer ring; and an inflatable saddle-shapedballoon disposed around the distal end of the tubular body, thesaddle-shaped balloon comprising a first peak and a second peak, thesecond peak displaced from the first peak along the longitudinal axis ofthe tubular body, wherein the saddle-shaped balloon is adapted tocompress a tissue of the natural orifice between the first peak and thesecond peak upon inflation to thereby occlude the natural orifice, andwherein the tubular body and the inflatable saddle-shaped balloon are ofa unitary one-piece construction.
 2. The surgical access port system ofclaim 1, wherein the proximal end of the tubular body comprises a funnelsegment.
 3. The surgical access port system of claim 1, wherein theinflatable saddle-shaped balloon has a diameter between 2 inches and 4inches.
 4. The surgical access port system of claim 1 further comprisingan inflation port located near the proximal end of the tubular body, theinflation port configured to inflate the inflatable saddle-shapedballoon.
 5. The surgical access port system of claim 4, wherein theinflation port is configured to allow gas to inflate the inflatablesaddle-shaped balloon.
 6. The surgical access port system of claim 4,wherein the inflation port is configured to allow liquid to inflate theinflatable saddle-shaped balloon.
 7. The surgical access port system ofclaim 1, wherein a low point of the inflatable saddle-shaped balloonbetween the first peak and the second peak is configured to compress thetissue of the natural orifice therebetween.
 8. The surgical access portsystem of claim 1 further comprising suture ties configured to furtherprevent dislodging of the surgical access port system from the naturalorifice.
 9. The surgical access port system of claim 1, wherein theinflatable saddle-shaped balloon is formed by heat-shrinking tubingaround the distal end of the tubular body.
 10. The surgical access portsystem of claim 1, wherein the inflatable saddle-shaped balloon tapersfrom a first larger diameter to a smaller second diameter, and whereinthe tapering is of a constant rate.
 11. The surgical access port systemof claim 10, wherein the inflatable saddle-shaped balloon tapers from adiameter of 4 inches to 2 inches.
 12. A surgical access port systemadapted for performing surgical procedures at a natural orificecomprising: an outer ring, wherein the outer ring is configured to bedisposed proximate the natural orifice of a patient; a tubular bodyhaving a longitudinal axis, a proximal end, and a distal end, whereinthe proximal end of the tubular body is coupled to the outer ring; andan inflatable balloon disposed around the distal end of the tubularbody, the inflatable balloon having at least two peaks that aredisplaced from each other, wherein the inflatable balloon is configuredto compress tissue of the natural orifice between the at least two peaksthereby occluding the natural orifice, and wherein the tubular body andthe inflatable balloon are of a unitary one-piece construction.
 13. Thesurgical access port system of claim 12 further comprising an inflationport located near the proximal end of the tubular body, the inflationport configured to inflate the inflatable balloon.
 14. The surgicalaccess port system of claim 13, wherein the inflation port is configuredto allow gas to inflate the inflatable balloon.
 15. The surgical accessport system of claim 13, wherein the inflation port is configured toallow liquid to inflate the inflatable balloon.
 16. The surgical accessport system of claim 12, wherein a low point of the inflatable balloonbetween adjacent peaks is configured to compress the tissue of thenatural orifice therebetween.
 17. The surgical access port system ofclaim 12 further comprising suture ties configured to further preventdislodging of the surgical access port system from the natural orifice.18. A surgical access port system adapted for performing surgicalprocedures at a natural orifice comprising: an outer ring, wherein theouter ring is configured to be disposed proximate the natural orifice ofa patient; a tubular body having a longitudinal axis, a proximal end anda distal end, wherein the proximal end of the tubular body is coupled tothe outer ring; and an inflatable saddle-shaped balloon disposed aroundthe distal end of the tubular body, the saddle-shaped balloon comprisinga first peak and a second peak, the second peak displaced from the firstpeak along the longitudinal axis of the tubular body, wherein thesaddle-shaped balloon is adapted to compress a tissue of the naturalorifice between the first peak and the second peak upon inflation tothereby occlude the natural orifice, and wherein the inflatablesaddle-shaped balloon tapers from a first larger diameter to a secondsmaller diameter, wherein the tapering of the inflatable saddle-shapedballoon from the first larger diameter to the second smaller diameter isconstant.